The Quality Assurance Lead is responsible for supporting the corporate-wide Quality mandate for the worldwide sale and distribution of ophthalmic ultrasound medical devices. This position is also responsible for activities related to quality compliance to internal SOPs and external regulatory bodies. The role proactively supports the rest of the QA/RA team and the wider business with issues related to the overall quality assurance, control, and compliance.

Responsibilities: 

• Lead and manage the Quality Assurance team within Operations. 
• Be a commercially focused Customer Voice within Operations, aligning the customer expectation of our quality with our delivery on that expectation.
• Preparation and delivery of monthly KPI presentations/ Metrics reporting (including, but not limited to Nonconformances, CAPA, Complaints, and supplier controls)
• Establish work priorities for Quality Control that are in line and supportive of the requirements of operational goals.
• Own, monitor and improve the Engineering Change Note system.
• Development and update of QMS procedures and associated Work Instructions and flowcharts to improve QMS process understanding
• Manage the complaint handling system, including efficient and timely processing of complaints, performing product evaluations, and reporting accurate complaint trending.
• Manage CAPA process and ensure effective coordination of investigations, root cause analysis, corrective and preventive actions, and effectiveness check according to timelines
• Provide Quality support for onboarding and evaluation of suppliers, including participation on the supplier review board and conducting supplier audits.
• Participate in support of audits representing key functional areas of responsibility as well as general support during the audit process. Audits may be from external regulatory bodies, customers, or external consultants.
• Provide QMS Induction training for new starters, and maintain quality and regulatory training records, as needed
• Train Quality Control personnel in product characteristics, attributes and quality control procedures, ensuring that personnel are trained appropriately to perform the tasks assigned and commensurate with their job descriptions.

Requirements:

• 3 years of Quality System experience in a medical device or manufacturing company
• Bachelor’s Degree in relevant field
• Must possess excellent interpersonal, communication (written and verbal), problem solving and negotiating skills
• Experience with FDA/notified bodies is a plus but not required. 
• Excellent attention to detail and ability to multi-task

About Express Employment Professionals

Express Employment Professionals is a leading staffing provider in Malvern, PA. Our goal is to help as many people as possible find good jobs by helping our clients find good people. We are locally owned and are involved in a wide variety of causes and organizations to strengthen our beautiful city of Malvern. We have placed many community members into positions that they enjoy! Join our team as an accounting assistant today!